A Study of SKB571 in Participants With Gastrointestinal Tumors
ConditionGastrointestinal Tumors
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
About this trial
This is an open-label, multicenter, phase II study. The purpose of this study is to evaluate the safety, tolerability and preliminary anti-tumor activity of SKB571 in participants with gastrointestinal tumors.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female, age ≥ 18 years and ≤ 75 years at the time of signing the informed consent form (ICF).
Participants must have histologically or cytologically confirmed gastrointestinal tumors.
At least one measurable lesion as assessed by the investigator according to RECIST v1.1.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Disqualifiers
Participants with other malignant tumors within 3 years before the first dose of study treatment.
History or current metastases to central nervous system.
Current uncontrolled concomitant diseases
Clinically severe lung damage due to complications of lung disorder
Trial design
Design model
Parallel
Treatments tested in this trial
SKB571 for injection
DrugIntravenous(IV) infusion(Q3W)
Treatment groups
120 Participants
are divided into 4 treatment groupsGroup A: Gastric Cancer/Gastroesophageal Junction Adenocarcinoma (GC/GEJ)Experimental treatment 1 intervention
Group B: Oesophageal Squamous Cell Carcinoma (ESCC)Experimental treatment 1 intervention
Group C: Colorectal Adenocarcinoma (CRC)Experimental treatment 1 intervention
Group D: Hepatocellular Carcinoma (HCC) or Bile Duct Cancer (BTC) or other types of gastrointestinal tumorsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Objective response rate (ORR)
Time frame
Up to approximately 24 monthsSecondary outcomes
1
Progression-free survival (PFS), duration of response (DOR), disease control rate (DCR), and overall survival (OS)
Time frame
Up to approximately 24 months2
Safety and tolerability
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) (based on CTCAE v6.0), clinically significant abnormal laboratory test results, etc.
Time frame
Up to approximately 24 months3
Maximum Plasma Concentration (Cmax) of SKB571-ADC
Blood Samples will be collected to determine the Cmax of SKB571-ADC in the plasma
Time frame
Up to approximately 24 months4
Immunogenicity
Blood Samples will be collected to measure Anti-drug antibody (ADA) against SKB571 in the serum
Time frame
Up to approximately 24 monthsOther outcomes
1
Correlation between biomarkers and efficacy
To evaluate the correlation between the expression levels of tumor-related genes in tumor tissues and efficacy
Time frame
Up to approximately 24 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov